MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP MEDLINE; LUMBAR LAMINECTOMY PACK

Catalog Number	DYNJT4553
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	Unspecified Infection (1930)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the facility, infections acquired with patients after the use of the custom laminectomy packs.Per the facility, several infection preventionists reviewed the recall letter associated with the packs and it is their view that the sponge would potentially cross-contaminate.No additional information at this time.It has been determined that the reported event caused or contributed to a death or serious injury.Based on the information reviewed, this is a reportable event as defined under 21 cfr 803.3.
Event or Problem Description
According to the facility, infections acquired with patients after the use of the custom laminectomy packs.

• Brand Name: MEDLINE
• Common Device Name: LUMBAR LAMINECTOMY PACK
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; 3 lakes drive; northfield
• Manufacturer Contact: alyssa reasner ; three lakes drive; northfield, IL 60093-2753
• MDR Report Key: 25397745
• Report Number: 1423395-2026-00226
• Device Sequence Number: 13436852
• Product Code: OJH
• UDI-Device Identifier: 10198459458323
• UDI-Public: 10198459458323
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 06/04/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: DYNJT4553
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/08/2026
• Initial Report FDA Received Date: 06/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: R-26-034
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown